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Simple versus informed choice invitations to screening

Didactic versus informed choice invitations to screening: balancing public health benefits and individual choice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73125647
Enrollment
1200
Registered
2006-01-09
Start date
2006-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Informed choice for screening for type two diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

1. Traditional invitation: This will be a brief letter based on previous invitations for screening tests, including diabetes and coronary heart disease. It will include: a. name of the condition i.e.

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 1200 men and women aged 40 to 69 years 2. In the top 20% of risk of undiagnosed diabetes on practice registers, defined by a validated risk score applied to routine data on general practice population registers. The Cambridge Diabetes Risk Score includes the following risk variables: a. age b. gender c. family history of diabetes d. smoking status e. prescription of steroid or anti-hypertensive medication f. body mass index

Exclusion criteria

Exclusion criteria: Patients considered by the practice nurse or General Practitioner to be unsuitable for the project, for example, people who are severely ill, will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Uptake of screening, which will be recorded by the practice nurses conducting the screening.

Secondary

MeasureTime frame
1. Intention to change behaviour to reduce risks of diabetes: behavioural intentions are good predictors of behaviour change. Three core behavioural intentions will be assessed in those attending: a. increasing physical activity b. restricting calories by eating low fat foods c. taking preventive medication, if indicated d. stopping smoking will also be assessed, when relevant 2. Self-reported behaviour assessed using standard questionnaires: a. physical activity b. diet c. smoking and use of medication to reduce risk of diabetes 3. Attendance for post screening blood tests and subsequent practice nurse advice will be recorded 4. Social deprivation: area (post code) and individual level measures (education, home ownership and access to car) will be used. Age, gender, and ethnic group and risk factors known before screening will also be recorded. 5. Risk stratification: all those attending will be given a risk score to indicate their risks of developing diabetes and experiencing a cardiovascular event over the next ten years. Those with confirmed diabetes, expected to be about 30 individuals, will also receive their Coronary Heart Disease (CHD) risk scores 6. Informed choice: choices to participate in screening will be classified as informed to the extent that they are based on understanding diabetes screening and reflect the decision-maker?s values, using a standardised method we have developed and validated in other screening contexts

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026